Cangrelor was administered 30 minutes before PCI (30 µg/kg bolus) with infusion continued 2 hours or until the end of the procedure (4 µg/kg/min). Clopidogrel 600 mg was administered at the end of cangrelor infusion.

Concomitant Medications:

Principal Findings:

Overall, 8,877 patients were randomized. In the cangrelor group, the median age was 62 years, 26% were women, 15% had stable angina, 25% had unstable angina, 49% had non-ST-elevation myocardial infarction (NSTEMI), 11% had STEMI, and 31% had diabetes. Drug-eluting stents were used in 59% and bare-metal stents in 38%. The median time from admission to PCI was 6.3 hours.

The primary outcome of death, MI, or urgent revascularization at 48 hours occurred in 7.5% of the cangrelor group versus 7.1% of the clopidogrel group (p = 0.59). Death was 0.2% versus 0.1%, MI was 7.1% versus 6.6%, urgent revascularization was 0.3% versus 0.6%, stroke was 0.2% versus 0.2%, and stent thrombosis was 0.2% versus 0.2%, respectively.

In a pooled analysis of the three CHAMPION trials (n = 24,910), the composite efficacy endpoint of death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours occurred in 3.8% of the cangrelor group versus 4.7% in the control group (p = 0.0007). Stent thrombosis: 0.5% vs. 0.8% (p = 0.0008), respectively. The composite safety endpoint of GUSTO severe or life-threatening bleeding at 48 hours occurred in 0.2% of the cangrelor group versus 0.2% in the control group (p = 0.49). ACUITY major bleeding: 4.2% vs. 2.8% (p < 0.001), GUSTO minor bleeding: 16.8% vs. 13.0% (p < 0.001), respectively.

Interpretation:

Among patients undergoing PCI, the use of cangrelor was not superior to clopidogrel; however, efficacy and safety outcomes appeared to be similar. Cangrelor did not reduce the outcome of death, MI, or urgent revascularization at 48 hours, although there was evidence for efficacy in a pooled analysis. Significant bleeding was similar between the two treatment arms except for a marginal increase in ACUITY major bleeding.

This trial complements the CHAMPION PLATFORM trial, which compared cangrelor to placebo, with clopidogrel given to all patients after PCI. Future studies may identify subgroups of patients who may benefit from this agent.